Fluid Management Device with Fluid Transport Element for use within a Body

ABSTRACT

A fluid management device for use in a mammalian body has at least one fluid transport element capable of interfacing with a mammalian body element to provide a substantially uninterrupted fluid conduit. The fluid conduit provides a fluid path between at least one fluid transport element and the storage element. A distal portion of the at least one fluid transport element is capable of extending away from the fluid storage element, and the at least one fluid transport element has a Wing Stiffness of less than about 10 g f .

CROSS-REFERENCE TO RELATED APPLICATIONS

This invention is a divisional of copending application to Carasso etal., U.S. Ser. No. 12/396,024, entitled “Fluid Management Device withFluid Transport Element for Use Within a Body”, filed Mar. 2, 2009 (AttyDocket No. PPC5071USCNT6), which is a continuation of application toCarasso et al., U.S. Ser. No. 10/882,913, entitled “Fluid managementDevice with Fluid Transport Element for Use within a Body”, filed Jun.30, 2004 (Atty Docket No. PPC5071USCIP), now U.S. Pat. No. 7,618,403,which is a Continuation-in-Part of application to Chase et al., U.S.Ser. No. 10/847,951, entitled “Fluid Management Device with FluidTransport Element for use within a Body”, filed May 14, 2004 (AttyDocket No. PPC-5071), now U.S. Pat. No. 8,247,642, the completedisclosures of which are hereby incorporated herein by reference for allpurposes.

This invention is also related to the following copending applicationsfiled on May 14, 2004: “Intravaginal Device with Fluid AcquisitionPlates” (U.S. Ser. No. 60/572,054; Atty Docket No. PPC-5073),“Intravaginal Device with Fluid Acquisition Plates and Method of Making”(U.S. Ser. No. 60/572,055; Atty Docket No. PPC-5072), “Method of UsingIntravaginal Device with Fluid Transport Plates” (U.S. Ser. No.10/848,347; Atty Docket No. PPC-5076), “Tampon with Flexible Panels”(U.S. Ser. No. 10/848,257; Atty Docket No. PPC-5074), “Method of Usingan Intravaginal Device with Fluid Transport Plates” (U.S. Ser. No.10/848,208; Atty Docket No. PPC-5075), and “Intravaginal Device withFluid Acquisition Plates” (U.S. Ser. No. 10/847,952; Atty Docket No.PPC-5070). In addition, this invention is related to “IntravaginalDevice with Controlled Expansion” (U.S. Ser. No. 60/584,772, refilled asU.S. Ser. No. 11/172,310; Atty Docket No. PPC-5089), filed on even dateherewith, the content of each of which is incorporated herein.

FIELD OF THE INVENTION

The present invention relates to fluid management devices for capturingand storing bodily fluid within the body.

BACKGROUND OF THE INVENTION

Devices for capturing and storing bodily fluid intravaginally arecommercially available and known in the literature. Intravaginal tamponsare the most common example of such devices. Commercially availabletampons are generally compressed cylindrical masses of absorbent fibersthat may be over-wrapped with an absorbent or nonabsorbent cover layer.

The tampon is inserted into the human vagina and retained there for atime for the purpose of capturing and storing intravaginal bodilyfluids, most commonly menstrual fluid. As intravaginal bodily fluidcontacts the tampon, it should be absorbed and retained by the absorbentmaterial of the tampon. After a time, the tampon and its retained fluidis removed and disposed, and if necessary, another tampon is inserted.

A drawback often encountered with commercially available tampons is thetendency toward premature failure, which may be defined as bodily fluidleakage from the vagina while the tampon is in place, and before thetampon is completely saturated with the bodily fluid. The patent arttypically describes a problem believed to occur that an unexpanded,compressed tampon is unable to immediately absorb fluid. Therefore, itpresumes that premature leakage may occur when bodily fluid contacts aportion of the compressed tampon, and the fluid is not readily absorbed.The bodily fluid may bypass the tampon.

To overcome this problem of premature leakage, extra elements have beenincorporated into a basic tampon to try to direct and control the flowof fluid toward the absorbent core.

For example, U.S. Pat. No. 4,212,301 (Johnson) discloses a unitaryconstructed digital tampon having a lower portion compressed preferablyin the radial direction to form a rigid, rod-like element, whichprovides a central rigidified elongated core and an upper portion leftsubstantially uncompressed. After insertion, the uncompressed portionmay be manipulated to contact the vaginal wall to provide an immediateseal against side leakage. The uncompressed portion allows for highabsorbent capacity immediately upon insertion. While this tampon mayallow for a certain amount of protection from bypass leakage, theuncompressed portion may become saturated before the compressed portionhas a chance to expand and become absorbent.

U.S. Pat. No. 6,358,235 (Osborn et al.) discloses a “hollow” bag-liketampon that may have an interior projection made from highly compressedabsorbent material. The interior projection is preferably attached tothe inside surface of the head of the tampon. The hollow tampon portionmay include at least one pleat in the absorbent outer surface and issoft and conformable. The tampon is not pre-compressed to the pointwhere the fibers temporarily “set” and re-expand upon the absorption offluid. The absorbent portions of the tampon can saturate locally, whichleads to bypass leakage.

U.S. Pat. No. 6,177,608 (Weinstrauch) discloses a tampon having nonwovenbarrier strips which are outwardly spreadable from the tampon surface toreliably close the free spaces believed to exist within a vaginalcavity. The nonwoven barrier strips extend about the tampon in acircumferential direction at the surface or in a helical configurationabout the tampon and purportedly conduct menstrual fluid toward thetampon surface. The nonwoven barrier strips are attached to the cover bymeans of gluing, heat sealing, needle punching, embossing or the likeand form pleats. The nonwoven barrier strips are attached to the tamponblank and the blank is embossed, forming grooves extending in alongitudinal direction. While this tampon purports to direct fluid tothe core, it attempts to achieve this by forming pockets of absorbentnonwoven fabric. In order to function, it appears that these pocketswould have to be opened during use to allow fluid to enter. However,based upon current understandings of vaginal pressures, it is notunderstood how the described structure could form such an opened volume.

U.S. Pat. No. 6,206,867 (Osborn) suggests that a desirable tampon has atleast a portion of which is dry expanding to cover a significant portionof the vaginal interior immediately upon deployment. To address thisdesire, it discloses a tampon having a compressed central absorbent corehaving at least one flexible panel attached along a portion of the sidesurface of the core. The flexible panel appears to provide the“dry-expanding” function, and it extends outwardly from the core awayfrom the point of attachment. The flexible panel contacts the innersurfaces of the vagina when the tampon is in place and purportedlydirects fluid toward the absorbent core. The flexible panel is typicallyattached to the pledget prior to compression of the pledget to form theabsorbent core and remains in an uncompressed state.

U.S. Pat. No. 5,817,077 (Foley et al.) discloses a method of preservingnatural moisture of vaginal epithelial tissue while a using a tamponwhere the tampon has an initial capillary suction pressure at the outersurface of less than about 40 mm Hg. This allows the tampon to absorbvaginal secretions without substantially drying the vaginal epithelialtissue. The multiple cover layers can be used to increase the thicknessof the cover material. While this represents a significant advancementin the art, this invention does not address by-pass leakage.

Additionally, U.S. Pat. No. 5,545,155 (Hseih et al.) discloses anexternal absorbent article that has a set of plates separated by spacerelements. The plates may be treated to affect wettability so that fluidwill flow easily across the surface. Extending through the upper plateis a plurality of openings, which allow fluid to flow with littlerestriction into the space between the upper and lower plates. When thefluid flows downward in the z-direction from the upper plate to thelower plate, it will then flow laterally in the x- and y-directions.Therefore, this external absorbent article can contain fluid gushes, butit does not appear to address the problems relating in particular tointravaginal devices, such as a tampon.

While the prior art is replete with examples of sanitary protectionarticles that capture bodily fluids both externally and intravaginally,these examples do not overcome the problem of premature failure oftenidentified as by-pass leakage that commonly occurs while using internalsanitary protection devices. Many solutions to this problem haveinvolved increasing the rate of expansion of a highly compressedabsorbent article.

Surprisingly, we have found a novel way to address the problem ofpremature failure. This invention is not dependent on the expansion ofthe compressed absorbent but rather directing the fluid by the use ofinter-plate capillary action. In our invention, we minimize localsaturation of the fluid storage element. Our invention also is effectivefor handling highly viscous menstrual fluid.

SUMMARY OF THE INVENTION

It has been discovered that fluids can be managed in a more effectiveway by coupling a fluid transport element with a fluid storage element,all held within the body. Several ways to achieve this are disclosedherein.

In one aspect of the invention, a fluid management device for use in amammalian body has at least one fluid transport element capable ofinterfacing with a mammalian body element to provide a substantiallyuninterrupted fluid conduit. The fluid conduit provides a fluid pathbetween at least one fluid transport element and the storage element. Adistal portion of the at least one fluid transport element is capable ofextending away from the fluid storage element, and the at least onefluid transport element has a Wing Stiffness of less than about 10g_(f).

In a further aspect, the invention provides a packaged intravaginaldevice. The packaged device includes a fluid storage element in fluidcommunication with a fluid transport element and a packaging element.The fluid storage element has a longitudinal axis and an outer surface.The fluid transport element has at least one flexible plate that iscapable of extending radially outward from the fluid storage element andthat is bendable about an axis substantially parallel to thelongitudinal axis of the fluid storage element, and the fluid transportelement has a Wing Stiffness of less than about 10 g_(f). The packagingelement substantially encloses the intravaginal device with at least aportion of a major surface of the flexible plate in contact with atleast a portion of the outer surface of the fluid storage element.

Other aspects and features of the present invention will become apparentin those ordinarily skilled in the art upon review of the followingdescription of specific embodiments of the invention in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 a shows a side elevation of a fluid management device having apair of fluid transport elements formed as extensions of a cover.

FIG. 1 b shows a transverse cross-section of 1 a along line 1 b-1 b.

FIG. 2 shows a transverse cross-section of a human vagina with a tamponaccording to FIG. 1 a disposed therein with one fluid transport elementextending away from the fluid storage element.

FIG. 3 a shows a side elevation of an alternate fluid management devicehaving a pair of fluid transport elements formed as extensions of acover.

FIG. 3 b shows a transverse cross-section of the device in 3 a alongline 3 b-3 b.

FIG. 3 c shows the transverse cross-section shown in 3 b, after theintroduction of a fluid between the plates of the fluid transportelement.

FIGS. 4 a-c show a series of coronal cross-sectional views of anintravaginal device according to the present invention during stages offluid discharge and absorption.

FIG. 5 a-c show enlarged cross-sections of alternate embodiments offluid transport elements of the present invention formed of polymericapertured formed film having differing orientations of the formed filmplates.

FIG. 6 shows an enlarged cross-section of an alternate embodiment of afluid transport element of the present invention having nubbles toseparate a set of film plates.

FIGS. 7 a-e show various aspects and orientations of an intravaginaldevice of the present invention.

FIG. 7 a: Side view of alternate embodiment with lateral parallelplates.

FIG. 7 b: Transverse cross-section 7 a.

FIG. 7 c: Transverse cross-section of alternate embodiment with parallelplates formed by cover pleats.

FIG. 7 d: Transverse cross-section of alternate embodiment with parallelplates partially extending into storage element.

FIG. 7 e: Side view of alternate embodiment with multiple extendingparallel plates.

FIG. 8 shows a transverse cross-section of an alternate embodimenthaving a pair of fluid transport elements partially extending into thestorage element.

FIG. 9 shows a side view of an alternate embodiment with multiple fluidtransport elements extending from the fluid storage element in planessubstantially perpendicular to its longitudinal axis.

FIG. 10 shows a transverse cross-section of a human vagina with a tamponaccording to FIG. 7 b disposed therein with the fluid transport elementsremaining wrapped around the fluid storage element.

FIG. 11 a shows a side elevation of an alternate embodiment of thepresent invention in which fluid transport elements connect a pluralityof fluid storage elements.

FIG. 11 b shows a transverse cross-section along line 11 b-11 b. in FIG.11 a.

FIG. 12 shows a transverse cross-section of the present invention havinga plurality of fluid transport elements folded against the fluid storageelement.

FIG. 13 shows a side elevation of a wrapped tampon within an applicator.

FIGS. 14 a-f show a Wing Bending Test apparatus.

FIG. 15 is a graphical representation of data of Table 1 generated usingthe Wing Bending Test apparatus of FIG. 14.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As used herein in the Specification and the Claims, the term “bodilyfluid” and variants thereof mean liquids that are produced by, secretedby, emanate from, and/or discharged from a human body.

As used herein in the Specification and the Claims, the term “fluids”and variants thereof relate to liquids, and especially bodily fluids.

As used herein in the Specification and the Claims, the term “sheet” andvariants thereof relates to a portion of something that is thin incomparison to its length and breadth.

As used herein in the Specification and the Claims, the term “parallelplate” and variants thereof relates to a system of at least tworelatively parallel sheets that are capable of moving fluids throughinter-plate capillary action. The individual “plates” in the system maybe flexible and/or resilient in order to move within their environment.However, they may be maintained in a substantially facing relationshipwith relatively constant separation at least in a localized portion oftheir structure (as compared with their relative length and width. Thus,two sheets could be fluted, but if the flutes are “nested”, the sheetswould generally remain generally parallel in any given localizedportion.

As used herein in the Specification and the Claims, the term“inter-plate capillary action” means the movement of fluid due to apressure difference across a liquid-air meniscus created within a gapbetween two substantially parallel plates. The two plates need not beheld apart a specific distance, although they should be separable toallow fluid to move between them by inter-plate capillary action. Ageneral equation providing the rise of a fluid between parallel platesis reported as:

$h = \frac{2\sigma*\cos \; \theta}{\rho*g*d}$

in which:

h is rise of fluid between plates

σ is the surface tension of fluid in contact w/plate

θ is contact angle

ρ is density

d is distance between plates, and

g is the gravitational constant Therefore, as long as the contact angle,θ, is less than 90°, there will be some capillary attraction.

As used herein in the Specification and the Claims, the term “porousmedium” and variants thereof relates to a connected 3-dimensional solidmatrix with a highly ramified network of pores and pore throats in whichfluids may flow.

As used herein, the term “separable plates” means any condition ofseparation of the first plate and the second plate, which allows fluidto move between the plates. This includes situations in which facingsurfaces of adjacent first and second plates are touching one another inportions of or across substantially all of their facing surfaces. Thisalso includes situations in which the facing surfaces of the adjacentfirst and second plates are separably joined together such that uponcontact with fluid, the surfaces separate enough to provide for fluid tomove between them. This further includes situations in which facingsurfaces of adjacent first and second plates are joined together, aslong as fluid may still move freely between the surfaces.

As used herein in the Specification and the Claims, the term “in fluidcommunication” relates to elements that are arranged and configured toallow fluid to move therebetween. The fluid movement may be byinterfiber capillary movement, intrafiber capillary movement, osmoticpressure, interplate capillary action, mechanical channeling, and thelike.

As used herein in the Specification and the Claims, the term “coupled”relates to the relationship between to portions of an integral structurethat are either portions of the same material (e.g., two portions of afolded sheet) or are materials that are joined together (e.g., twoseparate sheets that are bonded together).

As used herein in the Specification and the Claims, the term “fluidmanagement device” and variants thereof include, without limitation,patches for topical or transdermal applications, nasal pads or tampons,diapers, incontinence products, feminine hygiene products (includingsanitary napkins and intravaginal devices, such as tampons), body wipes,bedsheets and surgical gowns.

Referring to FIGS. 1 a & 1 b, one embodiment of this invention providesa fluid management device 10 having at least one fluid transport element12 in fluid communication with a fluid storage element 14 (FIGS. 1 a & 1b show two fluid transport elements 12 located on opposite sides of thefluid storage element 14). The device may also include a withdrawalmechanism, such as a string 16. The device may further include a fluidtransfer layer 18 to move collected fluid about the fluid storageelement 14. The fluid transport element 12 has at least one plate 20that has a distal portion 22 that is capable of extending away from thefluid storage element 14. When inserted, the at least one plate 20 canprovide two surfaces that can interact with vaginal walls “W” to createtwo sets of parallel plates as shown in FIG. 2, providing asubstantially continuous fluid path to the fluid storage element 14.

As mentioned above, the fluid management device 10 of the presentinvention may include a transfer or distribution layer 18. The transferlayer or distribution layer 18, if present, is generally positioned asan outer layer of the fluid storage element 14, although it may in turnbe enclosed by a cover 24, and the transfer layer usually directlycontacts the fluid storage element. If included, the transfer layer maybe made of any known material that will take up fluid and thendistribute and release it to an adjacent absorbent layer for storage.Transfer layers have a relatively open structure that allows formovement of fluid within the layer. Suitable materials for such transferlayers include fibrous webs, resilient foams, and the like.

The transfer layer provides a means of receiving bodily fluid from thefluid transport element and holding it until the fluid storage elementhas an opportunity to receive the fluid. The transfer layer is,preferably, more dense than the cover layer and has a larger proportionof smaller pores than does the cover layer. These attributes allow thetransfer layer to contain bodily fluid and hold it away from the outerside of the cover layer, thereby preventing the fluid from re-wettingthe cover layer and its outer surface. However, the transfer layer ispreferably not so dense as to prevent the passage of the fluid throughthe transfer layer and into the underlying fluid storage element.

The transfer layer may include various materials, including, forexample, fibrous webs, resilient foams, and the like. The transfer layermay include cellulose fibers such as from wood pulp, single component orbicomponent fibers that include thermoplastic materials (such as,polyester, polypropylene, polyethylene, among others) in fiber or otherforms, rayon, organic binders (such as, copolymers of vinyl, acrylicand/or other monomers that may be coated onto thermoplastic fibers orotherwise incorporated into the transfer layer) among other materialsknown to the art. The transfer layer may, for example, have a basisweight in a range from about 40 gsm to about 120 gsm, a thickness in arange from about 0.5 mm to about 4 mm, a density in a range from about0.03 g/cc to about 0.15 g/cc.

The mass of materials making up the transfer layer may be absorbent,even if the materials themselves are not absorbent. Thus, transferlayers that are made of hydrophobic, nonabsorbent fibers may be able toaccept large volumes of fluid into interfiber void spaces while thefibers themselves do not absorb any significant quantities of fluid.Likewise, open-celled foam structures that are made from nonabsorbentmaterials may also absorb fluid into the cells of the foam. The walls ofthe cells, however, do not absorb any fluid. The cumulative spaceswithin the transfer layer, i.e., the interfiber void spaces in thefibrous transfer layer or the open cells in the foam transfer layer,function much like a container to hold fluid.

Typically, transfer layer fibrous webs are made of resilient,nonabsorbent materials to provide void volume and to allow for freemovement of fluid through the structure. Transfer layers that are madefrom webs of mostly absorbent fibers absorb the fluid as it enters thestructure and do not distribute it throughout the rest of the structureas efficiently as webs containing non-absorbent materials. Transferlayer fibrous webs that include nonabsorbent materials are expected toprovide void volume and to allow for more free movement of fluid throughthe structure. Examples of such materials include polypropylene,polyethylene, polyester, bicomponent materials, nylon and mixtures orcombinations thereof. Alternative materials for transfer layers includeapertured film; it can be any other nonwoven material, such as, foam ornetting, which transports fluid and in combination with the cover, mayprovide masking of the fluid storage element.

A further alternate embodiment is shown in FIGS. 3 a-3 c in which anintravaginal device 10′ has at least one fluid transport element 12′ influid communication with a fluid storage element 14′ (FIGS. 5 a-5 c showtwo fluid transport elements 12′ located on opposite sides of the fluidstorage element 14′). The device may also include a withdrawalmechanism, such as a string 16. The fluid transport element has at leasta first plate 26 and a second plate 28. The first and second platescombine to provide a set of parallel plates, and the fluid transportelements 12′ are shown as extending radially away from the fluid storageelement 14′. Additional plates may also be incorporated into each fluidtransport element 12′.

The plates are arranged and configured to allow the introduction ofbodily fluid 30 to separate a plate from adjacent plate(s) (FIG. 3 c).At least one opening 32 allows the introduction of bodily fluids 30.Optionally, one or more spacer elements 34 can be inserted to establishand to maintain space between adjacent plates.

FIG. 3 b shows a pair of parallel plates prior to the introduction of afluid. In this view, the facing surfaces of the adjacent plates 26, 28are in contact. On the other hand, FIG. 3 c shows the set of parallelplates separated by a bodily fluid 30, providing an inter-platecapillary gap 36 between the inwardly oriented surface 38 of the firstplate 26 and the first surface 40 of the second plate 28. Thisinter-plate capillary gap 36 is sufficient to provide inter-platecapillary action to allow the fluid transport element 12′ to acquire, tospread, and to move bodily fluids 30 from the vagina to the fluidstorage element 14′. The first plate 26 also has an outwardly orientedsurface 42, and the second plate 28 also has an opposite surface 44.

In each of these embodiments, a distal portion 22′ of the fluidtransport element 12′ is capable of extending away from the fluidstorage element 14′ and thereby creating a substantially uninterruptedfluid conduit from a fluid source to the fluid storage element.

The plates 26, 28 can be made of almost any hydrophobic or hydrophilicmaterial, preferably sheet-like. The thickness of each plate is notcritical. However, it can preferably be selected from the range of fromabout 0.005 to about 0.050 inch. The materials of construction and thethickness of the plates should be designed so that they are sufficientlystiff and/or resistant to wet collapse when exposed to fluid. Suchmaterials provide a fluid transport element 12′ that is strong enough toprevent rupturing during handling, insertion, and removal and towithstand vaginal pressures during use.

In greater detail, FIGS. 4 a-c depict a tampon according to the presentinvention disposed within a user's vagina with one fluid transportelement 12′ extending across the flattened vagina. In FIG. 4 a, themenstrual fluid 30 flows from the cervix 46 into the formix 48 andvagina 50 above the intravaginal device (e.g., tampon 10′). The extendedfluid transport element 12′ disrupts the free flow of menstrual fluid 30along the full length of the vagina 50. In FIG. 4 b, the fluid transportelement 12′ has sufficient stiffness to remain extended during thetampon's absorption of menstrual fluid and to provide a substantiallycontinuous fluid path to the fluid storage element 14.

In contrast, FIG. 4 c shows a fluid transport element 12′ that lackssufficient stiffness and that has collapsed under the pressure of themenstrual fluid 30. This provides a substantially direct path for asignificant amount of menstrual fluid 30 to bypass the tampon.

Useful fluid transport elements 12′ in the form of one or more plate(s)(also described as “wings”) should have a “Wing Stiffness” (as definedbelow in the Examples) of less than 10 grams force (“g_(f)”).Preferably, the Wing Stiffness is about 0.4 g_(f) to about 4 g_(f), morepreferably about 0.5 g_(f) to about 3 g_(f), and most preferably, about0.5 g_(f) to about 2 g_(f).

In particular, materials useful for forming the fluid transport elementmay have properties such as thermobondability to provide means toincorporate it into the fluid management device. A representative,non-limiting list of useful materials includes polyolefins, such aspolypropylene and polyethylene; polyolefin copolymers, such asethylenevinyl acetate (“EVA”), ethylene-propylene, ethyleneacrylates,and ethylene-acrylic acid and salts thereof; halogenated polymers;polyesters and polyester copolymers; polyamides and polyamidecopolymers; polyurethanes and polyurethane copolymers; polystyrenes andpolystyrene copolymers; and the like. The fluid transport element mayalso be micro-embossed or apertured. Examples of films having aperturesinclude for example, three-dimensional apertured films, as disclosed inThompson, U.S. Pat. No. 3,929,135, and Turi et al, U.S. Pat. No.5,567,376, as well as two-dimensional reticulated film, such as thatdescribed in Kelly, U.S. Pat. No. 4,381,326. FIGS. 5 a-c illustratethree combinations of the apertured film of Thompson.

It may be helpful to keep the exposed surface of the fluid transportelement as smooth as possible. It may also be helpful to provide it witha low coefficient of friction. These characteristics may provide atleast two benefits: (1) the force required to insert the intravaginaldevice is reduced, and (2) it reduces the damage otherwise caused byscraping of soft, tender vaginal tissue during insertion, wearing andremoval. Plates 26 and 28 may be made from the same material oralternately, plate 26 may be made from a different material than plate28.

The parallel plates can have any physical structure to provide aresistance to fluid flow vector in the direction parallel to theinwardly oriented surface 38 of the first plate 26 and the first surface40 of the second plate 28 that is less than the resistance to fluid flowvector in the direction perpendicular to the plates. Preferably, theplates are made from any relatively smooth material. Suitable materialsinclude, without limitation, foil, waxed sheets, film, apertured film,and the like. For example fibrous or porous sheets may be coated with asubstantially continuous coating to provide a film- or foil-likesurface. Each plate does not need to be made of the same material as itscorresponding parallel plate. For instance the first plate 26 could bean apertured film to allow fluid to enter and the second plate 28 couldbe a solid film to move fluid to the storage element. Of course, theparallel plates must be able to transport fluid between the two layers.

It is preferable that the surface of at least one of the plates of thefluid transport element 12′ be sufficiently wettable by the bodilyfluids that the intravaginal device 10 is intended to collect (thisresults largely from a correlation of the surface energy of the platesurface and the bodily fluid(s)). Thus, the bodily fluid will easily wetthe plate, and capillarity between the plates will draw these bodilyfluids from a source to a fluid storage element that is in fluidcommunication with the fluid transport element.

Surface treatments can be used to modify the surface energy of theplates 26, 28. In a preferred embodiment a surfactant is applied toincrease the wettability of the outer or inner surfaces of at least oneplate. This will increase the rate at which the bodily fluids are drawnto and spread by plates, either between two plates or between a plateand the vaginal wall. The surfactant can be applied uniformly to eitherthe inner or outer surfaces or it could be applied with varying coatingweights in different regions.

A useful measure to determine the wettability of a plate surface is itscontact angle with 1.0% saline. Preferably, the contact angle with 1.0%saline is less than about 90 degrees.

In order to accomplish this, the materials of plates can be chosen fromthose materials that are known in the art to have low energy surfaces.It is also possible and useful to coat materials that have high-energysurfaces with a surface additive, such as a non-ionic surfactant (e.g.,ethoxylates), a diol, or mixtures thereof, in order to increase theirwettability by bodily fluids. Such additives are well known in the art,and examples include those described in Yang et al., U.S. App. No.2002-0123731-A1, and U.S. Pat. No. 6,570,055. Other means of increasingwettability can also be used, such as by corona discharge treatment of,for example, polyethylene or polypropylene, or by caustic etching of,for example, polyester.

The surfaces of the first and second plates facing each other can have avariety of surface textures, ranging from smooth to highly textured. Thetexturing element may be included as a spacer 34.

The desire to include spacers 34 or texture may be based on thematerial's ability to withstand wet collapse when simultaneouslysubjected to compressive forces and fluid.

The spacer elements 34 can be separate elements applied to one or moreof the plates, or they can be integral portions of a plate that extendaway from one of the plate's major surfaces. A representative list ofsuch separate spacer elements includes, without limitation, foamedmaterials such as polystyrene foam; particles such as beads andcrystals; discontinuous material such as netting, thread, wax, adhesive,any discrete element that causes a separation between the plates and thelike.

Integral spacer elements 34 can be thickened portions of the platematerial or deformations of the plate material. A representative list ofsuch an integral spacer element includes, without limitation, nubbles,embossments, corrugations, deformations, and the like. Included in thisdefinition are surface treatments that permanently bond a secondarymaterial to a surface of a first. One example of a deformation isprovided as the sidewalls 52 of a “three-dimensional” polymericapertured formed film material shown in FIGS. 5 a-c. FIG. 5 a shows thesidewalls 52 of inwardly facing surface 38 and the first surface 40 ofthe second plate 28 in facing relationship. FIG. 5 b shows a secondarrangement of the apertured film plates where the sidewalls 52 arenested. FIG. 5 c illustrates a third configuration of the apertured filmplates where the sidewalls 52 are on the inwardly facing surface 38 ofthe first plate 26, and sidewalls 52 are on the opposite surface 44 ofthe second plate 28.

In another example, shown in FIG. 6, the spacer elements are nubbles 54extending from the inward surface 38 of the first plate 26 and restingon the first surface 40 of the second plate 28.

In order to maintain stability against sliding of the plates withrespect to each other and changing of the space between them, it isacceptable, and may be preferable, to secure some local areas of contactbetween the spacer elements 34 and the adjacent plate or even betweenspacer elements 34 of two adjacent plates. The plates may be securedthrough means known to those of ordinary skill in the art. Arepresentative list of such securing means includes, without limitation,thermobonding, adhering, crimping, embossing, ultrasonic bonding orwelding, and the like. The adhesive may be applied between the spacerelements and the first and second plates. Preferably, the adhesive iswettable.

The at least one opening 32 can be at the edge of the plates, e.g.,edges of adjacent plates are separated or plates themselves may have atleast one opening. The openings need not be uniform. For example, oneopening 32 may be located at the edge of the plates and a plurality ofsmaller openings or apertures 56 can be distributed throughout one ormore plate. Preferably, each plate has a plurality of openingsdistributed throughout. An example of openings distributed throughout isan apertured film. The distribution can be uniform or arranged toprovide regions of higher open area and regions of lower open area.

A plurality of openings or apertures 56 may extend through at least oneof the first and second plates 26, 28. These apertures 56 may extendcompletely through the plate and may be present in both of the plates.The apertures 56 allow fluid that contacts the outward surface 42 of thefirst plate 26 or the opposite surface 44 of the second plate 28 to flowinto the inter-plate capillary gap 36 between the plates with as littlerestriction as possible. In the example of apertured film, it ispreferred that the total surface area of the plate occupied by theopenings is from about 5% to preferably about 50%. More preferably, itwill be from about 25% to about 45%. Having this much open area formedin a plate will allow fluid that is deposited on that plate to easilyflow into the inter-plate capillary gap 36.

It is preferable that any individual opening 32, 56 is large enough toeasily pass any highly viscous material, including menstrual fluid.While the geometry of the openings is not critical, the opening 32, 56should be sized sufficient to allow easy passage of non-absorbablematerial. If the apertures 56 are not circular, then the measurementshould be made across the narrowest part of the opening, which would bemost restrictive to the flow of non-absorbable material.

In the example of unapertured film that has an opening 32 at the ends ofthe plates 26, 28, the size of the opening 32 is a result of the fluid'sability to separate the plates.

It is preferred that the apertures 56 are large enough to let viscousfluid pass through but not too large to create too rough of a surface asto compromise the wearer's comfort. A preferred aperture 56 is circularand is between 10 mils and 40 mils in diameter. Most preferably it isbetween 18 mils and 27 mils.

Open area may be determined by using image analysis to measure therelative percentages of apertured and unapertured, or land, areas.Essentially image analysis converts an optical image from a lightmicroscope into an electronic signal suitable for processing. Anelectronic beam scans the image, line-by-line. As each line is scanned,an output signal changes according to illumination. White areas producea relatively high voltage and black areas a relatively low voltage. Animage of the apertured formed film is produced and, in that image, theholes are white, while the solid areas of thermoplastic material are atvarious levels of gray. The more dense the solid area, the darker thegray area produced. Each line of the image that is measured is dividedinto sampling points or pixels. The following equipment can be used tocarry out the analysis described above: a Quantimet Q520 Image Analyzer(with v. 5.02B software and Grey Store Option), sold by LEICA/CambridgeInstruments Ltd., in conjunction with an Olympus SZH Microscope with atransmitted light base, a plan 1.0.times. objective, and a 2.50×eyepiece. The image can be produced with a DAGE MTI CCD72 video camera.

A representative piece of each material to be analyzed is placed on themicroscope stage and sharply imaged on the video screen at a microscopezoom setting of 10×. The open area is determined from field measurementsof representative areas. The Quantimet program output reports mean valueand standard deviation for each sample.

Referring to FIGS. 7 a-13, the first and second plates 26, 28 may beseparate elements (i.e, adjacent to each other but not necessarilyjoined) or they may be extensions of the same sheet-like material, e.g.,formed by a fold in a sheet of material (as shown in FIGS. 7 a-7 e). Insuch a folded embodiment, the material is folded to form a pleat withthe first and second plates facing each other.

A preferred embodiment with pleats is shown in FIGS. 7 a-7 e, where thepleats 58 are folds in the cover material 60. The pleats 58 createplates that are bendable about an infinite number of bending axes(b_(1-i)-b_(1-i)) that are substantially parallel to the longitudinalaxis (X-X) of the product, which longitudinal axis extends through theinsertion end 62 and withdrawal end 64. These bending axes allow theplates to wrap around the product, either partially or completely. Onesuch bending axis (b₁ b₁) is shown in FIG. 7 b.

The fluid transport element 12′ is in fluid communication with the fluidstorage element 14′ and directs fluid from the vagina to the storageelement 14′. Generally, fluid will be directed from each fluid transportelement 12′ to a particular region of the fluid storage elementassociated with that fluid transport element. Thus, if the device hasonly one fluid transport element 12′, the fluid will contact the fluidstorage element in one interface 66.

Therefore, additional fluid transport elements 12′ directing fluid toadditional locations of the fluid storage element 14′ will improve theefficient usage of the fluid storage element 14′. For example, two fluidtransport elements 12′ could be directed to opposite sides of the fluidstorage element 14′, as shown in FIGS. 3 a-3 c. Each additional fluidstorage element 5 can direct fluid to additional interface locations 66of the fluid storage element 14′. For example, four evenly spaced fluidtransport elements 12′ allow fluid to be directed to each quarter of thefluid storage element 14′ surface as shown in FIGS. 7 a-7 e. Five ormore elements would provide even more direct access. This can allow thefluid to contact the fluid storage element 14′ uniformly and help toprevent or reduce local saturation of the fluid storage element 14′.

While the above description provides for direct fluid communicationbetween a fluid transport element 12′ and the fluid storage element 14′,direct fluid contact is not necessary. There can be fluid communicationthrough an intermediate element, such as a porous medium (e.g., a foamor fibrous structure), a hollow tube, and the like.

Enlarging the area of the interface 66 between the fluid transportelement 12′ and fluid storage element 14′ can also help to maximize thefluid communication. For example, elongating the interface by increasingthe length of the fluid transport element 12′ allows more fluid to flowinto the fluid storage element 14′.

The fluid transport element 12′ may extend in any orientation from thesurface of the fluid storage element 14′. It is not necessary for thefluid transport element to be on the surface of the fluid storageelement.

The inter-plate capillary gap 36 formed by first and second plates 26,28 can terminate at the interface 66 or can extend into and/or throughthe fluid storage element 14′. An example of the fluid transport element12′ extending into the fluid storage element 14′ is shown in FIG. 8. Theparallel plates can have additional layers on top of them as long asthese additional layers allow fluid to enter the plates. The first andsecond plates may be arranged such that they can be extended in a planethat is parallel to the longitudinal axis of the device. Alternately,they may also be arranged such that they can be extended in a plane thatis perpendicular to the longitudinal axis of the device, or in anyorientation between these extremes (not shown).

The first and second plates 26, 28 can end at the boundary of the fluidtransport element 12′ or can extend into the fluid storage element 14′.FIG. 8 shows two sets of parallel plates extending into the storageelement. The parallel plates can have additional layers on top of themas long as these additional layers allow fluid to enter the plates.

The fluid transport element 12′ may be formed to extend from the surfaceof the fluid storage element 14′ as in FIG. 3 a-3 c. In an alternativeembodiment, the withdrawal string 56 could be replaced by a pair oranother combination of ribbon-like parallel plates (not shown).

The fluid transport element 12′ can be made in any convenient shape,including semicircular, triangular, square, hourglass etc. Additionallythe two plates of the element do not have to be completely coextensive,as long as they are at least partially in a facing relationship.

The parallel plates forming the fluid transport element can be of anyflexibility as long as the material is able to transport fluid to thefluid storage element while the device is in use. It is also preferablethat the fluid transport element be sufficiently flexible to provide theuser with comfort while inserting, wearing and removing the device.

Parallel plates can be held in close proximity to the storage element ina variety of ways including directly or indirectly via an additionalelement to the storage element. A variety of methods can be used toattach the fluid transport element 12′ including but not limited toheat, adhesive, ultrasonics, sewing, and mechanically engaging the fluidstorage element 14′. An example of a heat-sealed attachment 68 is shownin FIG. 7 a.

The fluid transport element(s) 12′ can be attached at the sides,insertion end 62, and/or withdrawal end 64 of the intravaginal device10. Additionally, the fluid transport element(s) 12′ may be attached tothemselves and not to the storage element as in a parallel plates bagtype covering of the storage element. The parallel plates could also beattached to the withdrawal string 16. Additional means of attachment aredisclosed in the commonly-assigned, copending patent applicationsentitled. “Intravaginal Device with Fluid Acquisition Plates” (U.S. Ser.No. 60/572,054; Atty Docket No. PPC-5073), “Intravaginal Device withFluid Acquisition Plates and Method of Making” (U.S. Ser. No.60/572,055; Atty Docket No. PPC-5072), both filed on even date herewith,the contents of which are herein incorporated by reference.

Multiple fluid transport elements can be layered on top of each other orplaced next to each other. FIG. 9 shows a plurality of fluid transportelements 12′ extending from the sides of the storage element 14′ in aplane perpendicular to the axial direction thereof. These fluidtransport elements 12′ can be a variety of lengths and can be on part orthe entire surface.

During use, fluid transport element(s) 12, 12′ can take on manyconfigurations within the vagina. For example, a fluid transport element12″ may extend into the vagina away from the fluid storage element 14″,as shown in FIG. 2. Alternatively, the fluid transport element(s) 12′may remain wound about the fluid storage element 14′, contacting thevaginal wall “W” only through the outwardly oriented surface 42 (FIG.10).

The fluid storage element can be any convenient shape includingcylindrical, cup like, hourglass, spherical, etc. It can be an absorbentor a fluid collection device. It can be in separate sections with thefluid transport element(s) 12′ bridging or connecting the sections.FIGS. 11 a and 11 b shows a plurality of storage elements connected bytwo fluid transport elements 12′. (However, the outer storage elementsshould be removed before measuring the Wing Stability.)

The fluid storage element 14′ can be made of any composition known inthe art, such as compressed fibrous webs, rolled goods, foam etc. Thestorage element can be made of any material known in the art such ascotton, rayon, polyester, superabsorbent material, etc.

In one preferred embodiment, the fluid storage element 14′ is anabsorbent tampon 10. Absorbent tampons are usually substantiallycylindrical masses of compressed absorbent material having a centralaxis and a radius that defines the outer circumferential surface of thetampon. Such tampons are disclosed in e.g., Haas, U.S. Pat. No.1,926,900; Dostal, U.S. Pat. No. 3,811,445; Wolff, U.S. Pat. No.3,422,496; Friese et al., U.S. Pat. No. 6,310,296; Leutwyler et al.,U.S. Pat. No. 5,911,712, Truman, U.S. Pat. No. 3,983,875; Agyapong etal., U.S. Pat. No. 6,554,814. Tampons also usually include a cover orsome other surface treatment and a withdrawal string or other removalmechanism.

Absorbent materials useful in the formation of the absorbent bodyinclude fiber, foam, superabsorbent, hydrogels, and the like. Preferredabsorbent material for the present invention includes foam and fiber.Absorbent foams may include hydrophilic foams, foams that are readilywetted by aqueous fluids as well as foams in which the cell walls thatform the foam themselves absorb fluid.

Fibers may be selected from cellulosic fiber, including natural fibers(such as cotton, wood pulp, jute, and the like) and synthetic fibers(such as regenerated cellulose, cellulose nitrate, cellulose acetate,rayon, polyester, polyvinyl alcohol, polyolefin, polyamine, polyamide,polyacrylonitrile, and the like).

The fluid storage element may also be in the form of a collection cup.Examples of such devices are disclosed in Zoller, U.S. Pat. No.3,845,766 and Contente et al., U.S. Pat. No. 5,295,984. Collectiondevices are designed to assume a normally open, concave configuration,with an open side facing a user's cervix. The collection devices may befolded, or otherwise manipulated, to facilitate insertion into thevaginal canal

A withdrawal mechanism, such as withdrawal string 16, is preferablyjoined to the fluid management device 10 for removal after use. Thewithdrawal mechanism is preferably joined to at least the fluid storageelement 14, 14′ and extends beyond at least its withdrawal end 64. Anyof the withdrawal strings currently known in the art may be used as asuitable withdrawal mechanism, including without limitation, braided (ortwisted) cord, yam, etc. In addition, the withdrawal mechanism can takeon other forms such as a ribbon, loop, tab, or the like (includingcombinations of currently used mechanisms and these other forms). Forexample, several ribbons may be twisted or braided to provide parallelplates structures.

Tampons are generally categorized in two classes: applicator tampons anddigital tampons, and a certain amount of dimensional stability is usefulfor each type of tampon. Applicator tampons use a relatively rigiddevice to contain and protect the tampon prior to use. To insert thetampon into a body cavity, the applicator containing the tampon ispartially inserted into the body cavity, and the tampon can be expelledfrom the applicator into the body cavity. In contrast, digital tamponsdo not have an applicator to help guide them into the body cavity andrequire sufficient column strength to allow insertion without using anapplicator.

While the applicator tampon is protected by the rigid applicator deviceand the applicator tampon need not as have high a degree of columnstrength as a digital tampon, applicator tampons do require dimensionalstability (especially radial) to be acceptable for use. This dimensionalstability provides assurance, for example, that the tampon will notprematurely grow and split its packaging material or become wedged in atampon applicator.

Further, the fluid management device can be collapsed for packaging andinsertion. For example, at least a portion of a major surface of thefluid transport element 12′, such as the outwardly oriented surface 42,may be in contact with at least a portion of an outer surface of thefluid storage element 14′. This can be achieved by wrapping the fluidtransport element(s) around the fluid storage element 14′ (as shown inFIG. 7 b). Alternatively, the fluid transport element(s) 12′ may befolded or pleated (e.g., in an accordion-like manner as shown in FIG.12) against the fluid storage element 14′. The thus-compacted device canthen be packaged, (e.g., within an applicator or alone in a wrapper).FIG. 13 shows a wrapped tampon within an applicator 70 (in phantom).

EXAMPLES

The present invention will be further understood by reference to thefollowing specific Examples that are illustrative of the composition,form and method of producing the device of the present invention. It isto be understood that many variations of composition, form and method ofproducing the device would be apparent to those skilled in the art. Thefollowing Examples, wherein parts and percentages are by weight unlessotherwise indicated, are only illustrative.

Several variations of the tampon generally shown in FIGS. 7 a-7 e weremade using different fluid transport element materials (identifiedbelow) in Table 1. The wings on these tampons (Examples 1, 3-5, 7, and8) had 2 plies. Examples 2, 6, and 9 had single ply wings formed bycutting along the edge of the wing defined by the fold in the wingmaterial. The products were measured according to the “Wing BendingTest” (described below) to determine the Wing Stability as reported inTable 1.

TABLE 1 # of Avg. Peak Std. Example Material Description Plies Force(g_(f)) Min max Dev. 1 0.5 mil EMB 685 2 0.4 0.23 0.57 0.17 2 0.5 milEMB 685 1 0.108 0.09 0.135 0.024 3 o.b. ® SilkEase 2 1.54 1.14 2.19 0.57film cover 4 o.b. ® SilkEase 1 0.61 0.28 1.28 0.46 film cover 5 2 milEMB 685 2 3.56 2.85 4.77 1.05 6 1.0 mil MYLAR“D” 2 10.1 9.08 10.72 0.897 1.0 mil MYLAR“D” 1 0.89 0.75 1.09 0.18

EMB 685 is available from Tredegar Film Products (Richmond, Va. USA).O.b.® SilkEase tampon is available from Johnson & Johnson GmbH,Dusseldorf, Germany and the apertured film cover is described in U.S.Ser. No. 09/345,090. MYLAR “D” is available from GE Polymershapes FilmBusiness located in Devens, Mass. USA.

The data resulting from these tests are illustrated graphically in FIG.15. The material as configured for Example 2 was judged to beunacceptable in use and believed to collapse as shown in FIG. 4 c, whilethe material of Example 6 was judged to be at an upper extreme ofacceptable stiffness.

Wing Bending Test

One method to determine the stability of materials used in theconstruction of the fluid transport element is Wing Stiffness. Referringto FIG. 14 a-14 f, this test is carried out by placing a tampon 100 withone or more wing(s) 102 into a holding apparatus 104, and the holdingapparatus 104 was fixed into a clamp 106 with one wing 102 centeredunder a compression disc 108. The compression disc 108 has a downwardstroke of 12.7 mm, and contacts the wing 102 to bend it. The compressionpeak gram force is measured and recorded for a minimum of three samples.

Apparatus:

-   -   Instron machine    -   200 g Load cell    -   Compression disc (58 mm diameter)    -   Hollow tube with at least one slot (holding apparatus)    -   Stand with clamp to hold holding apparatus

Preparation:

-   -   A 200 gram load cell with 58 mm diameter compression disc was        installed in an Instron Model 1125-8175 testing machine    -   The load cell was calibrated    -   Test compression speed was set to 127 mm/minute    -   Test stroke length was set to 19 mm

Test Sample Set-Up and Procedure

-   -   Tampon 100 with wing 102 was inserted into the holding apparatus        104 with tampon base completely inside the holding apparatus 104        with the wing 102 extending out of slot 110;    -   The holding apparatus 104 was placed into the clamp 106 and        positioned with the wing 102 centered underneath the disc 108.        The outer edge 112 of the disc 108, closest to the holding        apparatus 104, was adjusted to provide a 5 mm gap therebetween        with the wing 102 extending beyond the gap sufficiently to        maintain engagement between wing 102 and with disc 108 during        test, at least until peak force is determined;    -   The compression disc 108 was adjusted to provide a 1-2 mm gap to        the wing 102 at the start of the compression stroke    -   The compression stroke of the Instron Model 1125-8175 was        initiated, and the compression disc 108 bends the wing 102    -   A minimum of three samples was tested, the peak force for each        sample was recorded, and the average peak force and standard        deviation were calculated

The specification and embodiments above are presented to aid in thecomplete and non-limiting understanding of the invention disclosedherein. Since many variations and embodiments of the invention can bemade without departing from its spirit and scope, the invention residesin the claims hereinafter appended.

What is claimed is:
 1. A packaged intravaginal device comprising: a. afluid storage element having a longitudinal axis and an outer surface;and b. a fluid transport element in fluid communication with the fluidstorage element, the fluid transport element comprising at least oneflexible plate that: i. is arranged and configured to extend radiallyoutward from the fluid storage element; and ii. is arranged andconfigured to bend about an axis substantially parallel to thelongitudinal axis of the fluid storage element; and iii. has a WingStiffness of less than about 10 g_(f); and iv. is arranged andconfigured to direct fluid to an associated interface with the fluidstorage element; and c. a packaging element that substantially enclosesthe intravaginal device with at least a portion of a major surface ofthe flexible plate in contact with at least a portion of the outersurface of the fluid storage element.
 2. The packaged intravaginaldevice of claim 1, wherein the at least one flexible plate has a WingStiffness of about 0.4 g_(f) to about 4 g_(f).
 3. The packagedintravaginal device of claim 2, wherein the at least one flexible platehas a Wing Stiffness of about 0.5 g_(f) to about 3 g_(f).
 4. Thepackaged intravaginal device of claim 3, wherein the at least oneflexible plate has a Wing Stiffness of about 0.5 g_(f) to about 2 g_(f).